What are the responsibilities and job description for the FDA Fellowship - Applying Large Language Models (LLM) in Drug Safety Reviews position at Zintellect?
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at Silver Spring, Maryland.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.
Research Project: This project is in the Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE). Our Office uses literature reviews to synthesize evidence from published literature to support regulatory decision-making. This ongoing project evaluates the large language model (LLM) performance for selected literature review tasks, including abstract and title screening, and information extraction. In joining this project, you will:
- Expand LLM benchmark datasets using FDA reviewers' literature reviews.
- Learn to develop prompts and design benchmark and validation studies to assess performance in additional literature review tasks.
- Research multi-step processes and agentic models, including comparisons with single-step chatbot models and their respective evaluation methodologies.
Learning Objectives: Guided by multidisciplinary mentors and collaborators with expertise in regulatory science, AI, clinical practice, pharmacoepidemiology, and pharmacovigilance, you will gain in-depth knowledge of evaluating and applying LLMs in literature reviews in drug safety evaluation. This unique opportunity provides firsthand experience with LLMs for enhanced drug safety review and exposure to drug safety practices in regulatory settings.
Mentor: The mentor for this opportunity is Hui Lee Wong (Huilee.Wong@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: June 30, 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Citizenship Requirements: This opportunity is available to U.S. Citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA Ethics Requirements
If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
- Non-employee nature of the ORISE appointment;
- Prohibition on ORISE Fellows performing inherently governmental functions;
- Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
- The fact that research materials and laboratory notebooks are the property of the FDA;
- ORISE fellow’s obligation to protect and not to further disclose or use non-public information.